MAUDE Adverse Event Report: ETHICON INC. GYNECARE MESH UNKNOWN; MESH, SURGICAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Micturition Urgency (1871); Incontinence (1928); Urinary Frequency (2275); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported by an attorney that the patient experienced prolapse and rectocele, with symptoms of urinary incontinence, nocturia, hesitancy, incomplete bladder emptying and dyspareunia.It was reported that the patient underwent a vaginal hysterectomy and pelvic floor repair on (b)(6) 2007 and mesh and another mesh were implanted.It was reported that she underwent a posterior pelvic floor repair procedure on (b)(6) 2010 to repair her anterior wall prolapse and rectocele and mesh was implanted.It was reported that the patient underwent pelvic floor repair on (b)(6) 2011 and on (b)(6) 2016.It was reported that she experienced spraying during urination, frequency, nocturia, urgency, urge incontinence, back, groin and pelvic pain, constipation, overactive bladder, sui, incomplete bladder emptying, dyspareunia and mesh retraction.It was reported that she underwent two surgical procedures to excise mesh, and surgery to divide vaginal adhesions in 2018.It was reported that she experienced a steroid injection and left pudendal nerve block.Other procedure is captured in separate file.No additional information was provided.

Manufacturer Narrative

Date sent to fda: 4/23/2020.Corrected information: d1, d2, g1, g5.

Manufacturer Narrative

Date sent to fda: 4/21/2020.H6 patient code: 3191 - rectocele, constipation, urination, incomplete bladder emptying.

• Brand Name: GYNECARE MESH UNKNOWN
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9981688
• MDR Text Key: 191007456
• Report Number: 2210968-2020-03225
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention